National Advisory Committee on Rural Health and Human Services, 38145 [2020-13670]
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Federal Register / Vol. 85, No. 123 / Thursday, June 25, 2020 / Notices
Application No.
Drug
Applicant
ANDA 078288 ....
Ondansetron HCl Injection, EQ 2 mg base/mL .......................
ANDA 080426 ....
Hydrocortisone Lotion, 0.5% ....................................................
ANDA 090813 ....
Levetiracetam Injection, 500 mg/5 mL (100 mg/mL) ...............
ANDA 201751 ....
ANDA 202684 ....
Articaine HCl; Epinephrine Bitartrate Injection, 4%; EQ
0.0085 mg base/1.7 mL; 4%; EQ 0.005 mg base/mL.
Levonorgestrel Tablets, 0.75 mg .............................................
Baxter Healthcare Corp., 1 Baxter Parkway, Deerfield, IL
60015.
Bausch Health Americas Inc., 400 Somerset Corporate Blvd.,
Bridgewater, NJ 08807.
Fresenius Kabi USA, LLC., Three Corporate Dr., Lake Zurich, IL 60047.
Hansamed Ltd., 4761 Tara Ct., West Bloomfield, MI 48323.
ANDA 204796 ....
Capreomycin Sulfate for Injection, EQ 1 gm base/vial ............
ANDA 205943 ....
Ethinyl Estradiol; Levonorgestrel Tablets, 0.02 mg, 0.15 mg;
0.025 mg, 0.15 mg; 0.03 mg, 0.15 mg; 0.01 mg, N/A.
Fluoxetine HCl Tablets, EQ 60 mg base .................................
ANDA 212191 ....
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of July 27, 2020.
Approval of each entire application is
withdrawn, including any strengths and
dosage forms inadvertently missing
from the table. Introduction or delivery
for introduction into interstate
commerce of products without
approved new drug applications
violates section 301(a) and (d) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 331(a) and (d)). Drug
products that are listed in the table that
are in inventory on July 27, 2020, may
continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: June 19, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–13661 Filed 6–24–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Committee on Rural
Health and Human Services
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
jbell on DSKJLSW7X2PROD with NOTICES
38145
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Secretary’s
National Advisory Committee on Rural
Health and Human Services
(NACRHHS) has scheduled a public
meeting. Information about NACRHHS
SUMMARY:
VerDate Sep<11>2014
19:15 Jun 24, 2020
Jkt 250001
Alvogen PB Research and Development LLC, U.S. Agent for
Lotus Pharmaceutical Co., Ltd. Nantou Plant, 44 Whippany
Rd., Suite 300, Morristown, NJ 07960.
Hisun Pharmaceuticals USA, Inc., U.S. Agent for Hisun Pharmaceutical (Hangzhou) Co., Ltd., 200 Crossing Blvd., 2nd
Floor, Bridgewater, NJ 08807.
Lupin Pharmaceuticals, Inc., 111 South Calvert St., Baltimore, MD 21202.
G&W Laboratories, Inc.
and the agenda for this meeting can be
found on the NACRHHS website at
https://www.hrsa.gov/advisorycommittees/rural-health/.
DATES: July 30, 2020, 12:00 p.m.–5:00
p.m. Eastern Time.
ADDRESSES: The meeting scheduled on
July 30, 2020, will be held by
teleconference/webinar. Instructions for
joining the meeting remotely will be
posted on the NACRHHS website 30
calendar days before the date of the
meeting. For meeting information
updates, go to the NACRHHS website
meeting page at https://www.hrsa.gov/
advisory-committees/rural-health/
meetings/.
FOR FURTHER INFORMATION CONTACT:
Steven Hirsch, Administrative
Coordinator at the Federal Office of
Rural Health Policy, HRSA, 5600
Fishers Lane, Rockville, Maryland
20857; 301–443–7322; or shirsch@
hrsa.gov.
and are seen as an essential part of the
economic fabric.
Members of the public will have the
opportunity to provide comments.
Public participants may submit written
statements in advance of the scheduled
meeting. Requests to submit a written
statement or make oral comments to
NACRHHS should be sent to Steven
Hirsch, using the contact information
above, at least 3 business days prior to
the meeting.
Individuals who plan to attend the
teleconference/webinar meeting and
need special assistance or another
reasonable accommodation should
notify Steven Hirsch at the address and
phone number listed above at least 10
business days prior to the meeting.
SUPPLEMENTARY INFORMATION:
NACRHHS provides advice and
recommendations to the Secretary of
HHS (Secretary) on policy, program
development, and other matters of
significance concerning both rural
health and rural human services.
At this meeting, NACRHHS will
discuss the development of a vision
statement that emphasizes rural
community transformation, sustainable
services, and resiliency. By focusing on
this vision, NACRHHS will define what
it wants to accomplish and how to
articulate a policy framework that
informs the HHS leadership and
empowers rural communities. The
intent is to use this process to create a
path forward that would help
NACRHHS identify policies that
empower rural communities to ensure
access to core health and human service
needs that are focused on local residents
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020–13670 Filed 6–24–20; 8:45 am]
BILLING CODE 4165–15–P
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
E:\FR\FM\25JNN1.SGM
25JNN1
Agencies
[Federal Register Volume 85, Number 123 (Thursday, June 25, 2020)]
[Notices]
[Page 38145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13670]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
National Advisory Committee on Rural Health and Human Services
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Federal Advisory Committee Act, this
notice announces that the Secretary's National Advisory Committee on
Rural Health and Human Services (NACRHHS) has scheduled a public
meeting. Information about NACRHHS and the agenda for this meeting can
be found on the NACRHHS website at https://www.hrsa.gov/advisory-committees/rural-health/.
DATES: July 30, 2020, 12:00 p.m.-5:00 p.m. Eastern Time.
ADDRESSES: The meeting scheduled on July 30, 2020, will be held by
teleconference/webinar. Instructions for joining the meeting remotely
will be posted on the NACRHHS website 30 calendar days before the date
of the meeting. For meeting information updates, go to the NACRHHS
website meeting page at https://www.hrsa.gov/advisory-committees/rural-health/meetings/.
FOR FURTHER INFORMATION CONTACT: Steven Hirsch, Administrative
Coordinator at the Federal Office of Rural Health Policy, HRSA, 5600
Fishers Lane, Rockville, Maryland 20857; 301-443-7322; or
[email protected].
SUPPLEMENTARY INFORMATION: NACRHHS provides advice and recommendations
to the Secretary of HHS (Secretary) on policy, program development, and
other matters of significance concerning both rural health and rural
human services.
At this meeting, NACRHHS will discuss the development of a vision
statement that emphasizes rural community transformation, sustainable
services, and resiliency. By focusing on this vision, NACRHHS will
define what it wants to accomplish and how to articulate a policy
framework that informs the HHS leadership and empowers rural
communities. The intent is to use this process to create a path forward
that would help NACRHHS identify policies that empower rural
communities to ensure access to core health and human service needs
that are focused on local residents and are seen as an essential part
of the economic fabric.
Members of the public will have the opportunity to provide
comments. Public participants may submit written statements in advance
of the scheduled meeting. Requests to submit a written statement or
make oral comments to NACRHHS should be sent to Steven Hirsch, using
the contact information above, at least 3 business days prior to the
meeting.
Individuals who plan to attend the teleconference/webinar meeting
and need special assistance or another reasonable accommodation should
notify Steven Hirsch at the address and phone number listed above at
least 10 business days prior to the meeting.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-13670 Filed 6-24-20; 8:45 am]
BILLING CODE 4165-15-P